HEMO-SANITAS SYRINGE— 510(k) K884921

Substantially Equivalent

Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger

FDA 510(k) clearance K884921 for HEMO-SANITAS SYRINGE, Substantially Equivalent on 1989-02-09. Applicant: Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger.

Clearance details

Applicant: Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1988-11-28
Decision date: 1989-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.